Beschreibung

In this role, you will ensure the quality and compliance of computer systems at the Lilly Alzey site, collaborating with global teams and overseeing projects from design to implementation. Your work will be crucial in maintaining high standards and supporting the launch of innovative healthcare solutions.

Anforderungen

• •Bachelor's degree in engineering, computers, or science-related field
• •At least 5 years working in pharmaceutical or medical device industry in QA or CSV roles
• •Previous CSQA / CSV experience
• •Proficiency with GMP computer systems validation
• •Strong oral and written communication skills
• •Strong technical writing skills
• •Accountability for maintaining a safe work environment
• •Ability to recognize and escalate potential long-term risks
• •Fluent in English
• •Proficiency in German is a plus
• •Previous facility or area start-up experience
• •Previous experience with SAP or other inventory management systems
• •Short duration assignment of 1-3 weeks in another site may be required

Aufgaben

• •Function as a CSQA with Global Facility Delivery and project staff
• •Coordinate design and startup activities with global and project teams
• •Provide technical and quality review of project computer system documents
• •Ensure compliance with Lilly Global Quality Standards
• •Assure computer systems are developed and maintained according to standards
• •Provide quality oversight throughout the computer systems lifecycle
• •Review and approve IT and Automation systems documents
• •Manage CSQA priorities and schedules for timely delivery
• •Assist with Data Integrity projects for the Alzey site
• •Participate in Audit Trail Review of Computer Systems
• •Conduct DI Assessment of Computer Systems to identify data vulnerabilities
• •Support technical capability building for cross-functional staff
• •Foster a strong quality culture through open communication and teamwork
• •Establish partnerships with Technology Team and system owners
• •Resolve or escalate compliance issues as necessary
• •Support QA Compliance team in executing the site readiness plan
• •Participate in self-led inspections and support regulatory inspections
• •Review and redline documents to ensure quality attributes are met

Tools & Technologien

Benefits